BEUDAMED
    FDA Enforcement Class II Terminated

    Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.

    Recall: Z-1098-2017 · Reported February 1, 2017

    Enforcement

    Recall Number
    Z-1098-2017
    Event ID
    76046
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Soft Computer Consultants, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 1, 2017
    Initiation Date
    October 6, 2016
    Classification Date
    January 26, 2017
    Termination Date
    August 21, 2019
    Address
    5400 Tech Data Dr, N/A, Clearwater, FL, 33760-3116, United States

    Description

    Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.

    Reason

    Software error. Potential for incorrect results

    Code Info

    Version: 35.5.2.0, 25.5.3.0, 25.5.3.1

    Distribution

    Worldwide Distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, WI, WV, and the countries of Hawaii and Puerto Rico Canada & Jamaica

    Quantity

    189 total